COMPASS - COpenhagen MenoPAuSe Study

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Menopausal Osteoporosis, Bone Markers

In brief

During menopause, estrogen levels drop while the level of another hormone - LH (luteinizing hormone) substantially increases. This hormonal shift is linked to bone Loss and other complications. Estrogen therapy can help, but some women avoid it due to the increased risk of blood clots and cancer. This project will investigate whether blocking LH could offer a safe alternative to alleviate symptoms and complications of menopause since it is known from previous research that high LH levels contribute to both bone deterioration and metabolic issues. The goal is to explore new treatment options that can improve health and quality of life for women both during and after menopause. This randomized clinical trial is a single center, sponsor-investigator-initiated single-blinded 8 weeks clinical trial with four parallel groups comparing the effect of an gonadotropin releasing hormone(GnRH)-analog with placebo, and with two additional arms given estrogen or testosterone on change on bone health in postmenopausal women with moderate-to-severe symptoms.

Key facts

Study ID: NCT07254429
Run by: Martin Blomberg Jensen
People needed: 192
Starts: 2025-10-02
Expected to finish: 2028-05-01
Last updated by the study team: 2026-03-02

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women >40 years and ≤65 at screening visit
A body mass index between 18-35
Confirmed menopause
Method 1
Spontaneous amenorrhea for ≥12 consecutive months
Negative urine hCG test
Method 2
Spontaneous amenorrhea for ≥6 months
FSH >30 mIU/L
Negative urine hCG test
Moderate to severe vasomotor symptoms (VMS)
Within the 7 days prior to randomization, participants must report ≥ 14 moderate to severe VMS per week

You may not qualify if…

Current or previous hormone replacement therapy (HRT)
Vaginal estradiol/vaginal inserts (e.g. Vagifem®) can be used, but will have to be pause 2 weeks prior to randomization and throughout the study period
Menopausal Hormone Therapy (MHT) can be used by participants, but must be paused 6 weeks prior to inclusion.
Current or previous cancer diagnosis
Except for basal cell carcinoma
Known BRCA gene mutation
Current hyperthyroid disease
Osteoporosis
Major psychiatric diagnosis including ongoing medication e.g. selective serotonin re-uptake inhibitors (SSRIs)
Known prolonged QT or other known clinically significant abnormal ECG, including taking medication that can prolong QT interval (e.g. sotalol, dronedarone, amiodarone, methadone, and several antipsychotic drugs)
Previous myocardial infarction or heart failure
Previous thromboembolic event
The use of opioids, anticoagulating treatment or unwilling to pause fish oil/Omega-3 supplements 3 days prior visit 1 and 3
Current alcohol or drug abuse
Hypertension treated with more than two drugs
Severe history of allergy, hypersensitivity, or intolerance to drugs
Moderate to severe liver and kidney disease (eGFR <60 mL/min)
Diagnosed with type 1 or 2 diabetes
Chronic diseases requiring immunomodulatory treatments such as rheumatoid arthritis, inflammatory bowel disease, and vasculitis etc.
Known uterine fibroids, Endometriosis, Systemic lupus erythematosus (SLE), otosclerosis, severe migraine or sleep apnea
Known Epilepsy or previous seizures or convulsive disorder

Where it is running

Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev. — Herlev, Denmark (enrolling)

Full record on ClinicalTrials.gov

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